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Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

Sponsor
Nada Mahmoud Abd El-Azim Mohamed (Other)
Overall Status
Recruiting
CT.gov ID
NCT04658602
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
 N/A

Detailed Description

Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.

For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel groupsParallel groups
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Quadruple ( Participant, Care Provider, Investigator, Outcomes Assessor ) Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.
Primary Purpose:
Treatment
Official Title:
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns : Two-arm Randomized Controlled Trial (Part III)
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Direct composite restoration

Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )

Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement
Active Comparator: Preformed metal crowns

Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )

Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement

Outcome Measures

Primary Outcome Measures

  1. Pain after the restoration Binary (yes or no ) [12 month]

    Questionnaire

Secondary Outcome Measures

  1. Acceptability of the treatment Binary (yes or no ) [12 month]

    Questionnaire

  2. Restoration quality score index [12 month]

    (FDI criteria: criterion marginal adaptation

  3. Health-related quality of life changes by the therapies [12 month]

    Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14)

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Children with MIH in one fully erupted molar or more.

  2. Age ranging from 7-12 years.

  3. cooperative children

  4. Good general health.

Exclusion Criteria:

  1. patients participating in other experiments.

  2. Patients with parents planning to move away within the following year.

  3. Patients with only mildly affected MIH molars that do not require extensive restorative treatment.

  4. MIH-affected molars that have a very poor prognosis and require extraction.

  5. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of oral and dental medicine,Cairo University Cairo Egypt

Sponsors and Collaborators

  • Nada Mahmoud Abd El-Azim Mohamed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nada Mahmoud Abd El-Azim Mohamed, Doctor/Dentist, Cairo University
ClinicalTrials.gov Identifier:
NCT04658602
Other Study ID Numbers:
  • ttt of teeth with MIH part III
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nada Mahmoud Abd El-Azim Mohamed, Doctor/Dentist, Cairo University
MIH
Additional relevant MeSH terms:
Dental Enamel Hypoplasia

Study Results

No Results Posted as of Dec 8, 2020